FDA Classifies Medtronic's Worldwide Voluntary Field Action on Guidewires as Class I Recall

You are subscribed to Recalls, Market Withdrawals and Safety Alerts for U.S. Food & Drug Administration (FDA).

This information has recently been updated and is now available.

 

FDA Classifies Medtronic's Worldwide Voluntary Field Action on Guidewires as Class I Recall

11/15/2013 08:42 PM EST

Medtronic, Inc. (NYSE: MDT) announced today that the U.S. Food and Drug Administration (FDA) has classified the company's recently initiated voluntary field action related to certain guidewires as a Class I recall. Based on an internal investigation following a limited number of complaints, including one patient injury, Medtronic began notifying hospitals and distributors worldwide the week of Oct. 21 that some models of its guidewires from recent lots have the potential for the coating on their surface to delaminate and detach.

. For detailed information pertaining to this Recalls, Market Withdrawals and Safety Alerts message, please click the link at the beginning of this bulletin.

---

Manage your FDA Subscriptions:

• Update your preferences or unsubscribe
• Questions about this service? support@govdelivery.com
• Other inquiries? webmail@oc.fda.gov

---

This email was sent to filter@clubhouseb.com using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420